PROBEAT-CR— 510(k) K191801

Substantially Equivalent

Hitachi , Ltd.

FDA 510(k) clearance K191801 for PROBEAT-CR, Substantially Equivalent on 2019-09-13. Applicant: Hitachi , Ltd.. Device class: 2.

Clearance details

Applicant: Hitachi , Ltd.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2019-07-03
Decision date: 2019-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hitachi-Shi, JP

Download summary PDF View on FDA.gov ↗

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More clearances from Hitachi , Ltd.

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Recalls naming K191801

K-number listed on FDA's recall record

Z-1430-2026 — Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CRClass II·Ongoing·Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha·20260206

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191801.

Data sourced from openFDA. This site is unofficial and independent of the FDA.